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Apixaban, Rivaroxaban, and Warfarin in Patients With Cirrhosis and AF
Quick Takes
- Patients with AF and cirrhosis experienced lower rates of major bleeding when initiating apixaban as compared to rivaroxaban or warfarin.
- There was a notably lower rate of hemorrhagic stroke in patients with AF and cirrhosis starting apixaban as compared to warfarin.
- There was no difference in thromboembolic events across all treatment groups.
Study Questions:
What are the effectiveness and safety outcomes associated with apixaban versus rivaroxaban and versus warfarin in patients with cirrhosis and atrial fibrillation (AF)?
Methods:
The authors conducted a population-based cohort study using two US claims data sets (Medicare and Optum Clinformatics Data Mart). Patients with both cirrhosis and AF who were initiating an oral anticoagulant were 1:1 propensity-score matched based on the anticoagulant initiated (apixaban, rivaroxaban, warfarin). The primary outcomes included efficacy outcomes (ischemic stroke or systemic embolism) and safety outcomes (major hemorrhage). All-cause mortality was also assessed. Cox proportional hazards models were used to estimate the difference between the treatment groups.
Results:
The authors created two propensity-matched pairs of new oral anticoagulant cohorts, 2,785 each of apixaban or rivaroxaban and 2,852 each of apixaban or warfarin. When compared to new apixaban users, those initiating rivaroxaban had a higher rate of major hemorrhage (rate difference, 33.1/1,000 patient-years; 95% confidence interval [CI], 12.9-53.2; hazard ratio [HR], 1.47; 95% CI, 1.11-1.94) but not a significantly different rate of ischemic events or death. When compared to new apixaban users, those initiating warfarin had a higher rate of major hemorrhage (rate difference, 26.1/1,000 patient-years; 95% CI, 6.8-45.3; HR, 1.38; 95% CI, 1.03-1.84). There was a notable increase in the risk of hemorrhagic stroke with warfarin as compared to apixaban (rate difference, 9.47/1,000 patient-years, 95% CI, 2.2-17.2; HR, 2.85; 95% CI, 1.24-6.59). There was no significantly different rate of ischemic events or death between apixaban and warfarin.
Conclusions:
The authors conclude that among patients with cirrhosis and AF, initiators of rivaroxaban or warfarin, as compared to apixaban, had higher rates of major hemorrhagic events.
Perspective:
Use of direct oral anticoagulants, including apixaban and rivaroxaban, is not recommended first-line over warfarin for most patients with AF. One group where clinicians have been uncertain about this preference is in those with cirrhosis, given that both apixaban and rivaroxaban have package label warnings for patients with advanced cirrhosis. This observational study found favorable bleeding risk associated with initiating apixaban as compared to rivaroxaban or warfarin in a cohort of patients with cirrhosis and AF. However, only one-third of the cohort had a history of prior hepatic decompensation and approximately 15-20% had evidence of ascites or hepatorenal syndrome. As such, these results may not apply to patients with the most severe forms of cirrhosis but will likely help provide reassurance to clinicians trying to manage patients with mild to moderate chronic liver disease (e.g., Child-Pugh Class A-B).
Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Anticoagulation Management and Atrial Fibrillation, Atrial Fibrillation/Supraventricular Arrhythmias
Keywords: Anticoagulants, Atrial Fibrillation, Liver Cirrhosis
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